The newest research about living with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (ME/CFS)/fibromyalgia, with personal observations
(the most pertinent parts of long articles will be highlighted for the reader)

About The Author

On March 4, 1988, I was diagnosed with Post-Viral Syndrome, which CDC soon decreed had to be referred to by the silly name "Chronic Fatigue Syndrome". My symptoms definitely traced back to a severe flu-like illness with a 105 fever for several days in mid-February 1987.
Despite relapses and increasing symptoms, I continued to work full-time as a legal secretary/paralegal -- even when I had no Quality of Life because I had to spend every non-working hour in bed so I could work the next day -- until February 2000, when months of severe sleep disturbance and ever-increasing symptoms (due to sleeping 2 hours or less a night due to the pain) cost me my job.
The doctors and judge didn't want to hear about failed attempts to return to work; they just assumed I don't want to work. "Don't confuse me with facts, my mind is already made up."
Since ADA will not force an employer to provide the accommodations I need, I started my own business so I could lie down whenever I needed to. I do proofreading and editing from home.
Visit www.CFSfacts.org or CFS Facts at YahooGroups or on Facebook if you want to learn the truth behind the myths.

When the first edition of Chronic Fatigue Syndrome: A Treatment Guide was completed we were asked what we would do with the manuscript if a cure was found before the publication date. "Burn it!" we said. We weren't being naive. The late nineties were a heady time for CFS advocacy and support groups.

If you don't have a Kindle, you can get Amazon's free Kindle for PC app.

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Like Erica, I naively believed that a cure was just around the corner. I was diagnosed by an Ivy League-trained virologist ... when someone like that says "I'm working on it", you believe in miracles.

25 years later, I am no longer naive and I no longer believe in miracles. I now believe that the only way we're going to get a cure is patient power. DIY. OK, not so much "do" it yourself as Fund It Yourself. There are some good research programs from people we trust -- Dr. Enlander at Mount Sinai in New York and Dr. Peterson at Simarron in Nevada -- where we can send our money with full faith that they're investigating ME/CFS and not some psychobabble.

Chronic fatigue syndrome is little understood, and Ampligen's approval would give patients some standing with their insurers, Klimas said.

"Even a single approved therapy, even if it were one I choose not to use, would be very helpful when I am arguing with insurance companies to legitimize the condition and that it is serious enough to require an intervention," Klimas said.

* * *

Even if Ampligen isn't approved, at least stories about it are getting the word out that CFS is a legitimate disease.

Hopes on a miracleDesperate Norwegians travel to California for treatment-with samecancer medicine looks to cure CFS patients in Bergen.

Maria Gjerpe is 44 years and has had ME since she was 16. For justover a half ago she lay under the covers 21.5 hours a day. Now shesits full of pep at Haukeland University'cancer ward. In the hand, shehas a cannula in face a wide smile and eyes that glows. Beside herstands chief Øystein Fluge and oncology nurse Helle Øvrebø. Rarely dothey see so striking transformations in patients.

- When you came here for the first time in April, it was as far as wegot up from the wheelchair to the bed. You were shaky, unwell and verydifficult to talk with, recalls Øvrebø.

- I hardly remember it. All that concerned was to survive, replies Gjerpe.

This is the fourth time she's in Bergen to be given the cancer drugRituximab. Earbud and the dark sunglasses she wore on her first,exhausting journey from Oslo, she long since put away.

- How's it going? ask Fluge

- I must exert myself for not only a grin: I am perfectly well!

- How is your activity level?

- I go for walks in nine miles, without break and without gettingtired. I read, lectures and writes feature articles, reply Gjerpeproud. In better times she has been able to train as a doctor, but ittook her 12 years.

- There is no longer any doubt: You approaching complete response tomedicine, concludes Fluge, while Nurse Øvrebø almost feel honored.

- I did not like this was possible. It's incredibly nice to be withwhen people get their lives back. I had no idea that so many sufferedso terribly with ME, she says.

STUMBLED INTO. It had no powers over Øystein Fluge and his colleagueProfessor Olav Mella either, until they observed something surprisingin 2004: A woman with ME had lymphoma and was treated with fourdifferent chemotherapy regimens. Six or seven weeks out of one ofthem, she was suddenly temporarily relieved by ME symptoms.

Doctors analyzed cell poisons she had received and decided that it wasprobably a drug that affects B-cells (a type of white blood cell),which had had the unexpected effect of ME disease. After she recoveredfrom cancer, why they chose to give her the cancer drug Rituximab,which targeted reducing the number of B-cells.

Mella and Fluge knew that Rituximab also be applied to autoimmunediseases such as rheumatoid arthritis and lupus. Could it be that the"mysterious disease" ME belonged to the same category?

Having seen the response in another two pilot patients, implementingthe a small, double-blind study. 15 ME patients received within 14days two infusions of Rituximab, as many received only saline(placebo), and neither the doctors nor the subjects knew who got what.

The results of the study were published in the medical journal PLoSOne last fall and attracted attention world over 10 of the 15 who hadreceived Rituximab, were significantly better. But jubilation over thebreakthrough was not unanimous.

SHOCK. Ignite a peppery, roll in a minefield and pour gasoline on thefire. About as explosive, the Norwegian ME debate.

In one corner: those who believe ME / CFS is a psychosomatic illnessthat can be cured with cognitive techniques such as Lightning Process(LP) or mindfulness. In the other: those who argue that ME is aclearly defined physical diagnosis that will be cured as researchersfind biomarker and forensic medicine.

Duellantene lashed out swing punches to beat counterpart knockout.With the imminent danger to frame even those who have inadvertentlyended up somewhere in the middle.

People like Mella and Fluge.

- Our field is cancer. We had no idea how inflamed ME discussion is.Fasten a ME conference in London sat patients and hollering andwhistling at debate panel. That aggression is not exactly accustomedto cancer conferences. But there also experiencing the patients to agreater degree to be taken seriously, says Mella.

- I stay away from all the noise on the Internet, avoid google ME andchronic fatigue syndrome.

War of words is just distracting. I understand why we are taken to theincome a purely biological view, but that is to underestimate us. Thepsychic and the physical hangs course together, says Fluge.

CALIFORNIA DREAMIN '. After their study became known last year, FlugeMella and received over 500 inquiries, many of them utterlyheartbreaking, from ME sufferers who desperately want to trymedication.

- I am almost sick when I read. It is lidelseshistoríe bylidelseshistoríe, but it gives inspiration to work on this, saysØystein Fluge.

Some medicine he can not offer those who contacts. It can, however,the American physician Andreas Kogelnik at the Open Medicine Instituteoutside San Francisco. He has begun to accept Norwegian CFS patientsfor examination and treatment.

- We have been contacted by over a dozen Norwegian patients, and a setof them are now participating in our studies, says he to A magazine.

One of them is "Maya". She lives in Oslo Area, is 28 years old, hashad ME since she was 16, and the last four years the disease has takenover her life. She is partially disabled, has at times been in need ofcare, and she knows that for every helpless today as yesterday, bemore dreams in ruins.

She believes that medicine made her a little better, but that theeffect slackening journey is so insanely exhausting. In January, shetravels back in the wheelchair and companion, for another infusion.

- I have to pay for this with loans all sides, which puts me in afuture financial difficulty. I no guarantee that the treatment goingto work, and it is therefore an immense physical strain to travel sofar. Yet I have not really been in doubt. I think no one in mysituation would have been.

For not only is life put on pause; she also fear being regarded withsuspicion at all levels, that many believe she only makes itself. Itis not to endure.

- I can not let this stand untested. For the chance to get myself andmy life back, I am willing to sacrifice everything.

FRUSTRATED. In Mid-Norway live "Unni" another of Kogelnik's Norwegianpatients. When Fluge and Meller study published last fall, was23-year-olds hope. That soon was turned to frustration.

- To know that there was a medicine that might help me, but I at bestto wait for several years to make, was cruel. I want the to live alife now!

At Christmas last year, she started and family to probe thepossibility of â Rituximab get outside Norway. They knew it would costenormously, both of money, time and effort, but decided to let it rip.

- For me it would have been luxury to take the mail without anyproblems. At times I have to lie down and recuperate for â grab aglass of water. Travel to California seemed impossible. In additiondid we that I could end with no response or with serious side effects.Yet I decided to try.

So far she has been three times in Kogelnik. Without getting better.The last month is she on the contrary become much worse.

- It's awful tough. I do not know about deterioration due tomedication. But I try to keep up hope.

The next visit is scheduled for January. The family has already spentover 200,000 dollars on travel and treatment. Unni knows she is lucky.

- There will be a class distinction between ME patients either aloneor with family's assistance may buy assistance and those who can notafford. I think it is incredibly unfair.

NOT MYSTERIOUS. Since the first study of its fame in October, have theverbose enthusiastic Bergenser Fluge and Mella, which carry serenityof his home district Kongsvinger deep forests, conducted a open-labelstudy of 28 patients who know that they receive Rituximab.

The results are not yet published, but at conferences, there have beenshows that also in this study, approximately two of the threeparticipants significantly response. Kogelnik report correspondingpayout on their patients, and says that he is now of organizing adouble-blind and placebo-controlled Rituximab study at six or eightinternational research centers.

- I will get back to coordinate with Fluge and Mella, he assures.

Meanwhile, only two of the ten recovered in Fluge and Mella's firststudy avoided relapse. Much suggests therefore, the medication must betaken over a long time, as it is used by people with arthritis.

- If the ME is an immunological disease, so we believe it will be therule, says Mella.

But this is also a disease that can be cured with mental copingtechniques? Mella and Fluge invalidates no experience of ME suffererswho after three days of Lightning Process Course gets up from the bedand declares healthy, but tries to balance them against their ownRituximab studies.

Their theory is that CFS symptoms not always directly caused by theunderlying disease.

- We know that especially in the frontal lobe brain through veryactive thinking can affect and suppress the involuntary nervoussystem. That's probably a major reason for the LP and other extremeforms of cognitive treatment can provide as rapid effect. For somelasting effect, and then probably the underlying disease state "Burnedout." In others effect of such techniques are at best transient. Whenwe believe that the underlying cause, the disease state, probablystill present, explain Mella.

NOT EXPERTS. Many other question remains: Why respond some ofRituximab after six weeks, others for six months? And what about thosewho do not have known effect at all, neither in the first or secondtrial?

Plays possibly immune system T-cells a larger role than B-cells with them?

- We try not to appear to be experts on ME. Both our studies has clearweaknesses: The first was small, the other is open and without theplacebo group. But we are quite confident that we have fallen intosomething that is true, says Mella.

- A mysterious illness is not. When their mechanisms underlyingavailable, we think, of course, that's it! For we know that Rituximabworks, what remains is to find definitive answer as to why, addsFluge.

COLLECTION. That's why searched the Research Council for nine millionto implement a large, double-blinded and randomized national study in140 ME patients next year.

Last week came the answer: 34 projects of more than 400 applicants inhealth, medicine and biology were awarded a total of 234 million.Mella and Fluge were not among them.

The reactions were not long in coming. Patients and familiesdesperately, Ema Solberg called the decision sad, both Maria Gjerpeand ME Association announced that it would start rolling penny, aupset Laila Dâvøy (KrF) rushed right the Parliament's rostrum anddemanded that the government immediately allocate 9 million, andHealth Minister Jonas Gahr Støre expressed surprise the ResearchCouncil's decision, however, without giving binding promises.

The only ones who seemed to make the decision calmly, was Mella and Fluge.

- It actually came as no big surprise. There were many very strongcandidates, and we had under 10 percent chance of getting a yes. Butwe continue to plan our study. I'm sure there will be fundseventually. There is appropriated two million both this year and nextyear budget, and with time we will have accumulated enough money. ForFluge and me this is not a tragedy. But it's a pity for the patients,said Mella. oIa.henmo@aftenposten.no

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Zumba Dancer

Lene Loe (39)Married, two children

I've had ME since 2007. When I got the offer to participate in thefirst study to Mella and Fluge, I lay in my room, full of anxiety,despair swell. They could offered anything.

I had nothing to lose.

As month after month passed without any thing happened, I was sure Ihad received placebo. But then. After about six months, it began toease.

It lasted not. One year after infusion, I was almost back where Istarted. Fortunately I got Rituximab again from the autumn of 2010,and experienced exactly the same: After six to seven months I wasbetter. I, who had not been in town for years, endured the sudden bothlight and sounds.

Now I have received infusions of between three and six monthintervals, the last in February, and shape improvement has beenremarkable. I am back at work as a teacher, zumba dancing and going toyoga. I have nearly repressed how sick I was.

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Up and down and up and down and up

Mariann Ripel (41)Married, three daughters

- I was one of those who received Rituximab in Mella and fly firststudy in 2008. The effect came after just seven weeks. I got betterand better. Started to go for walks and socialize. It lasted approx.six months.

Then it turned.

In 2009, I join the second their study. The same thing happened thistime, but now I got multiple doses, and progress only continued. InJanuary 2011, I received the last dose. Then I had ten months withoutrecurrence. So said the pang.

Within two months I was back in the bottom.

In January this year, I luckily be the pilot for the next trial, andhistory has repeated itself. It is just not possible to say that thisis a coincidence. Now I work 40 percent as a nurse and has begun tofurther study to be a nurse.

The way it looks now, I can not continue on the medication forever. Ihope that the disease burns out, and try not to think that I can get anew relapse. No one knows what the future holds, I can in a caraccident tomorrow, and I refuse to take your sorrows in advance. Ihave one infusion again. After that I have at least ten good months tolook forward to. Those I enjoy.

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Newly saved

Hanna (30)Married

When I was in the first study, I slept up to 20 hours a day, was dizzyand nauseous. I had a huge hope that medication would help, but knewthat it was 50 per cent chance that I was given medicine withoutsubstance. Then after a year I was informed that I had receivedplacebo, I was so happy. Then I knew you it was still likely that themedicine would work on me.

I got to be involved in the maintenance study in 2010. Mella and Flugesaid it probably would not take long before I noticed any response, soI was not really waiting, but after infusions in October and November,I knew that something was happening in the body. Suddenly, I wasrefreshed after sleeping. After a few weeks I asked my husband if wewere to walk, and so it has continued.

I will say that I'm 100 percent healthy. I have finished Master degreegave-my friend and is working full time, but I have not told about thedisease to my bosses. I fear that it will cleave to me if I seek newjobs. Therefore, I will remain anonymous in A magazine well. There aremany prejudices ME. Many people think that it is really just to pullhimself together.

I can only imagine how painful it is to read about people like me, forthose who do not get medicine. I've got my life back and hope thateveryone gets this chance. I seems certain newly saved, but it's sowonderful to live and work normally. Now I've been healthy for twoyears. I am no longer afraid of relapse. This is going to hold.

Hemispherx Biopharma is seeking approval from the U.S. Food and DrugAdministration for the drug, Ampligen. The product, which been indevelopment for more than two decades, was reviewed Thursday by theagency's arthritis-drugs advisory panel, which is made up of non-FDAmedical experts. In an 8-to-5 vote, the panel said the company didn'tprovide sufficient data to support the approval of Ampligen. The voteamounts to a recommendation that FDA not approve the drug.

Several panel members said they struggled with their decisions becauseit appears the drug works in certain patients even if it wasn'tstrongly shown in the clinical data presented to the panel.

"I think the advisory panel in general hopes there will be aneffective drug and hopes this might be the drug" for chronic fatiguesyndrome, said Lenore Buckley, the panel's chairwoman and a professorat Yale School of Medicine. "We are interested in seeing more data." Adecision by the FDA on whether to approve Ampligen is expected byearly February.

Almost three dozen patients or family members testified in person orvia video before panel, urging them to approve Ampligen. Anita KathrynPatton, who's had chronic fatigue syndrome for more than 20 years, wasfirst given Ampligen in 1997.

"It was like rising from the dead," Ms. Patton said of her diseaseimprovement. She and some other patients are receiving Ampligenthrough a special access program at a cost of about $25,000 a year.

At issue is whether Ampligen, which is the drug's proposed brand name,is effective and safe. The FDA said there was missing data in clinicalstudies that made it hard to tell whether the drug is safe. Potentialsafety concerns include infections and liver problems. FDA medicalreviewers questioned whether the data meet drug-approval requirementsdemonstrating "substantial evidence" of safety and efficacy, oreffectiveness.

Theresa Michele, an FDA team leader, said the agency believes thatchronic fatigue syndrome is a serious disease that needs treatments,but said clinical studies submitted in support of products have tomeet federal drug approval standards showing "substantial" safety andeffectiveness. "We have to be certain a drug works and we clearly knowwhat the risks are," Dr. Michele said.

The FDA and the company differed on whether one of the main clinicalstudies reached a goal showing a statistically significant testshowing patients receiving the drug were able to walk on a treadmillfor a longer period than patients receiving placebo injections.

The company said on average there was an improvement of about oneminute while the FDA said the difference appeared to be about 20seconds.

"Regardless of the [measurement] approach there's a consistent patternof benefit in the data, which favor Ampligen," said William Carter,Hemispherx chief executive. At a minimum, Dr. Carter said, the drug"prevents further disease progression." After the meeting, Dr. Cartersaid he had no comment.

Chronic fatigue syndrome, also known as myalgic encephalomyelitis, isbelieved to affect more than one million Americans, according to theCenters for Disease Control and Prevention. The condition is marked bysevere fatigue, muscle pain and memory and concentration problems. Itisn't known what causes the condition and there are currently nospecific treatments.

Ampligen, an injectable drug, is believed to boost the body's immunesystem and fight viruses.

Thursday, December 20, 2012

Note: Although depression and anxiety are listed as symptoms offibromyalgia technically they are separate disorders which can co-occurwith any disease. They may be a normal response to chronic pain. Asalways, a common caveat with medical populations is that symptoms thatcommonly occur with disease, including fatigue or loss of energy, changesin sleep patterns and changes in appetite, may be misinterpreted byhealthcare providers, researchers or patients as mood-related particularlywhen specificity and severity are lacking

Fibromyalgia is a complex illness to diagnose and to treat. There is notyet a diagnostic test to establish that someone has it, there is no cureand many fibromyalgia symptoms—pain, fatigue, problems sleeping and memoryand mood issues—can overlap with or get mistaken for other conditions.

A new Mayo Clinic study suggests that many people who have fibromyalgia,especially men, are going undiagnosed. The findings appear in the onlineedition of the journal Arthritis Care & Research. More research is needed,particularly on why men who reported fibromyalgia symptoms were less likelythan women to receive a fibromyalgia diagnosis, says lead author AnnVincent, M.D., medical director of Mayo Clinic's Fibromyalgia and ChronicFatigue Clinic.

"Health care providers may not think of this diagnosis when face to facewith a male patient with musculoskeletal pain and fatigue," Dr. Vincentsays. "These findings need to be explored further."

Researchers focused on Olmsted County, Minn., home to a comprehensivemedical records pool known as the Rochester Epidemiology Project, and usedmultiple methods to try to get at the number of people over age 21 withfibromyalgia. They used the epidemiology project to identify just over3,000 patients who looked like they might have fibromyalgia:

Roughly a third had a documented fibromyalgia diagnosis. That amounted to1.1 percent of the county's population 21 and older. In the second method,researchers randomly surveyed Olmsted County adults using the AmericanCollege of Rheumatology's fibromyalgia research survey criteria. Thecriteria include the hallmarks of fibromyalgia: widespread pain andtenderness, fatigue, feeling unrested after waking, problems with memory orthinking clearly and depression or anxiety, among other symptoms.

Of the 830 who responded to the survey, 44, or 5.3 percent, met thosecriteria, but only a dozen had been diagnosed with fibromyalgia. Based onthe study's findings, the researchers estimate that 6.4 percent of people21 and older in Olmsted County have fibromyalgia—far more than have beenofficially diagnosed with it. Fibromyalgia is more common in women, but mencan get it too.

The discrepancy between the number of people reporting fibromyalgiasymptoms and the number actually diagnosed with the condition was greatestamong men, the study found. Twenty times more men appeared to havefibromyalgia based on their survey response than had been diagnosed, whilethree times more women reported fibromyalgia symptoms than were diagnosed.

"It is important to diagnose fibromyalgia because we have effectivetreatments for the disorder," says co-author Daniel Clauw, M.D., directorof the University of Michigan Health System Chronic Pain & Fatigue ResearchCenter. Studies also show that properly diagnosing people with fibromyalgiareduces health care costs, because they often need far less diagnostictesting and fewer referrals looking for the cause of their pain, Dr. Clauwsays.

thank you Erik for adding the Mount Sinai ME Center to your site, ........... we are now recruiting patients for the Post Exertion Malaise (PEM) study which will refute or support the CDC (US) / PACE (UK) concept of exercise treatment in ME and CFS. ...... PEM is a facet of the Canadian Consensus Criteria used in the diagnosis of ME and CFS. We will examine immune status , cytokines, virology, enzymatic changes in major organs and the genome in patients and controls before and after exercise.

Monday, December 17, 2012

Misdiagnosis on a grand scale?Our editorial in the most recent Breakthrough magazine (Autumn 2012) seems to have stuck a chord, so the text is now available on our website http://bit.ly/RmOw5M

The key point – that many people referred from primary care with a diagnosis of ME/CFS are found to have another, treatable condition when assessed at a specialist clinic – might not surprise patients themselves, since many have already questioned their own diagnosis and/or have had difficulties with the "patient-GP encounter" (for the patient view see http://bit.ly/TqoM61 and for the GP view http://bit.ly/V5myQ9 ). Yet, the accumulating evidence of misdiagnosis on such a scale should be astonishing to healthcare professionals, and ought to greatly concern the NHS as an institution. Something is far wrong, and it needs to be fixed.

* * *

I've said the same thing. Some doctors will never diagnose CFS, no matter what; they'll call it depression even when there are symptoms reported that aren't seen in depression. Other doctors will diagnose CFS in any patient who's tired, regardless of the reason.

Dr. Bell has noted that fully half of people initially diagnosed with hypochondria are eventually diagnosed with something very real that matches the symptoms they complained of all along.

Sunday, December 16, 2012

Note: One of the difficulties in treating pain is that scientists have yetto develop an accurate "blood test" for pain making it difficult toobjectively measure pain and thus pain relief. And no one drug (or othertreatment) is a miracle for every single person who tries it regardless ofthe condition or disease but particularly in areas where there isdiagnostic confusion and overlap.

Amitriptyline is a tricyclic antidepressant that is widely used to treatchronic neuropathic pain (pain due to nerve damage) and fibromyalgia, andis recommended in many guidelines. These types of pain can be treated withantidepressant drugs in doses below those at which the drugs act asantidepressants.OBJECTIVES:

To assess the analgesic efficacy of amitriptyline for chronic neuropathicpain and fibromyalgia.To assess the adverse events associated with theclinical use of amitriptyline for chronic neuropathic pain and fibromyalgia.SEARCH METHODS:

We searched CENTRAL, MEDLINE, and EMBASE to September 2012, together withreference lists of retrieved papers, previous systematic reviews, and otherreviews; we also used our own handsearched database for older studies.SELECTION CRITERIA:

We included randomised, double-blind studies of at least four weeks'duration comparing amitriptyline with placebo or another active treatmentin chronic neuropathic pain or fibromyalgia.DATA COLLECTION AND ANALYSIS:

We extracted efficacy and adverse event data, and two study authorsexamined issues of study quality independently. We performed analysis usingtwo tiers of evidence. The first tier used data meeting current beststandards, where studies reported the outcome of at least 50% painintensity reduction over baseline (or its equivalent), without the use oflast observation carried forward (LOCF) or other imputation method fordropouts, reported an intention-to-treat (ITT) analysis, lasted 8 to 12weeks or longer, had a parallel-group design, and where there were at least200 participants in the comparison. The second tier used data that failedto meet this standard and were therefore subject to potential bias.MAIN RESULTS:

Twenty-one studies (1437 participants) were included; they individuallyinvolved between 15 and 235 participants, only four involved over 100participants, and the median study size was 44 participants. The medianduration was six weeks. Ten studies had a cross-over design.

Doses of amitriptyline were generally between 25 mg and 125 mg, and doseescalation was common.

There was no top-tier evidence for amitriptyline in treating neuropathicpain or fibromyalgia.

Combining the classic neuropathic pain conditions of PDN, postherpeticneuralgia (PHN) and post-stroke pain with fibromyalgia for second-tierevidence, in eight studies and 687 participants, there was a statisticallysignificant benefit (risk ratio (RR) 2.3, 95% confidence interval (CI) 1.8to 3.1) with a number needed to treat (NNT) of 4.6 (3.6 to 6.6).

The analysis showed that even using this potentially biased data, onlyabout 38% of participants benefited with amitriptyline and 16% withplacebo; most participants did not get adequate pain relief.

Potential benefits of amitriptyline were supported by a lower rate of lackof efficacy withdrawals; 8/153 (5%) withdrew because of lack of efficacywith amitriptyline and 14/119 (12%) with placebo.More participantsexperienced at least one adverse event; 64% of participants takingamitriptyline and 40% taking placebo.

The RR was 1.5 (95% CI 1.4 to 1.7) and the number needed to treat to harmwas 4.1 (95% CI 3.2 to 5.7). Adverse event and all-cause withdrawals werenot different.AUTHORS' CONCLUSIONS:

Amitriptyline has been a first-line treatment for neuropathic pain for manyyears. The fact that there is no supportive unbiased evidence for abeneficial effect is disappointing, but has to be balanced against decadesof successful treatment in many patients with neuropathic pain orfibromyalgia.

There is no good evidence of a lack of effect; rather our concern should beof overestimation of treatment effect. Amitriptyline should continue to beused as part of the treatment of neuropathic pain or fibromyalgia, but onlya minority of patients will achieve satisfactory pain relief.

Limited information suggests that failure with one antidepressant does notmean failure with all.It is unlikely that any large randomised trials ofamitriptyline will be conducted in specific neuropathic pain conditions orin fibromyalgia to prove efficacy.

WASHINGTON --For about a million Americans, Thursday will be a seminalday. That's when some of them come before the Food and DrugAdministration to petition for approval of a potent and controversialdrug, a so-called Lazarus drug.

The drug, first synthesized by Hemispherx Biopharma, Inc., ofPhiladelphia, in the 1970s, is Rintatolimod (tradename Ampligen),which is used to treat chronic fatigue sSyndrome, also known asmyalgic encephalomyelitis. It is a grim but little-understood diseaseof the immune system, resulting in collapse, pain, confusion andsensitivity to light and noise.

Patients and their doctors want the drug, but there is concern thatthe FDA will fault -- as it has in the past -- the scope of theclinical trials and the documentation of collateral effects.

The FDA is expected to rule early next year.

The sickest of the sufferers, mostly bedridden and some so sick theyhave to lie in dark rooms for 18 hours a day, are pinning their hopeson a drug that will allow them to rise from their sick beds, thus theLazarus appellation.

Dr. Andreas Kogelnik, who runs the Open Medicine Institute in MountainView, Calif., puts the chances of FDA approval for Ampligen at just 50percent. Although he is rooting for the drug to be approved, he saysthe FDA may require more data on collateral effects. This has happenedin the past and the FDA has not been satisfied with previousapplications.

Dr. Daniel Peterson, who has been treating CFS since 1984 in InclineVillage, Nev., said recently that he thinks fewer than 100 people atany one time, either through trials or compassionate waivers, are onAmpligen. The drug is only available in a few states, most prominentlyNew York and Nevada. It is very expensive (about $25,000 for a courseof treatment) and has to be administered through intravenous infusion-- a long, slow process, at regular intervals.

According to Kogelnik, some patients react poorly right off the bat,while others show substantial improvement almost immediately.

Mary Schweitzer, a CFS sufferer, said that she can only walk when sheis getting Ampligen. She travels regularly from her home in Delawareto New York, where Dr. Derek Enlander, who specializes in CFS, is amajor proponent of Ampligen therapy.

Even devout proponents of Ampligen do not tout it as a cure but as atherapy that helps them move about and approach a kind of normalcy.

Anita Patton, who lives in Nevada, said in prepared testimony for theFDA: "Ampligen increased my ability to eradicate viruses. I previouslyhad not been able to walk up the stairs to then being able to exercisefor 19 minutes on the treadmill.

"The joy that even a small improvement can give a person, to be ableto do household tasks or get out of the house and use my body to takewalks, is something that many patients do not have. The quality oflife of a patient with this horrible illness is so difficult not tocare for yourself and have to endure severe pain in muscles andnerves, being too exhausted to even take a shower or lift my arms tofix my hair.

"The suffering is immense. Many patients have to lie in bed for 18hours a day, as I did before Ampligen, needing care and not having alife of their own. Many patients have lost all friends and family."

When patient activists face the government in various hearings, it ispainfully asymmetrical, it seems to me. The sick tell sad stories ofsuffering, loss of love as well as health, while the government peopletalk abstractly about patient loads, international diseasedefinitions, allocation of resources and appear self-important ratherthan appalled at the suffering that passes before them.

The patients turn to the government for recognition, but thegovernment turns them into a statistic.

--

(Llewellyn King is executive producer and host of "White HouseChronicle" on PBS. Email: lking(at)kingpublishing.com.)

Some years ago, parents complained that their children's disease got only $35 per patient. I made sure to keep up on that topic to point out that PWCs would be happy to swap places, since we get only $1 per patient (if you believe CDC's estimate of 4M patients in the US).